相关临床试验
28
3 进行中
药物批准
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监管机构
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成立时间
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已完成
15
53.6%
尚未招募
3
10.7%
招募中
10
35.7%
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- Japan's Ministry of Health, Labour and Welfare granted marketing authorization to eptinezumab for the prevention of migraine attacks in adults, Lundbeck announced on Sept. 16, 2026. - Eptinezumab is the only intravenous CGRP-targeted preventive migraine treatment approved in Japan and is now launched in more than 30 markets worldwide. - The authorization was supported by the Phase III SUNRISE trial in a predominantly Asian chronic migraine population and the SUNSET long-term extension study in Japanese patients. - The approval paves the way for Lundbeck's first launch in Japan as marketing authorization holder, enabling the company to operate independently in the Japanese market.
- Japan's Ministry of Health, Labour and Welfare approved Ono Pharmaceutical's XCOPRI (cenobamate) tablets on September 16, 2026, for patients with partial-onset seizures. - Approval was based on the multinational Phase 3 YKP3089C035 trial in South Korea, China and Japan, where all cenobamate doses beat placebo on seizure reduction. - In that trial, cenobamate 400 mg produced a 100% median reduction in seizure frequency during maintenance versus 25.9% for placebo, with 52.4% of patients seizure-free. - Cenobamate is now approved in more than 45 countries and regions, and Ono is running further Phase 3 studies in PGTC seizures and pediatric partial-onset seizures in Japan.
- Chugai Pharmaceutical received regulatory approval from Japan's MHLW for Alecensa as the world's first tumor-agnostic therapy for advanced or recurrent ALK fusion gene-positive solid tumors, including pediatric patients. - The approval was based on the TACKLE study, which demonstrated a 76.5% response rate in ALK fusion gene-positive patients across all cohorts, with a safety profile consistent with previous studies. - This milestone expands Alecensa's use beyond non-small cell lung cancer and anaplastic large cell lymphoma to a wide range of cancer types harboring ALK gene abnormalities. - FoundationOne CDx Cancer Genomic Profile received companion diagnostic approval to identify patients who could benefit from this tumor-agnostic treatment approach.
- Japan's Ministry of Health, Labour and Welfare has approved Dupixent (dupilumab) for treating bronchial asthma in children aged 6 to 11 years with severe or refractory disease inadequately controlled by existing therapy. - The approval is based on the global Phase 3 VOYAGE trial, which demonstrated that Dupixent significantly reduced severe asthma exacerbations by 54% to 65% and improved lung function by 4.68% to 5.32% compared to placebo. - Dupixent becomes the first and only biologic medicine to demonstrate improved lung function in this young patient population in a randomized Phase 3 trial. - The drug inhibits IL-4 and IL-13 pathways, key drivers of type 2 inflammation, and has already been approved in 50 countries worldwide for pediatric asthma treatment.
- Japan's Ministry of Health, Labour and Welfare has approved Bylvay (odevixibat) as the first once-daily ileal bile acid transport inhibitor for treating pruritus in progressive familial intrahepatic cholestasis patients. - The approval addresses a critical unmet need for approximately 100 children and infants in Japan suffering from this rare, life-threatening genetic liver disorder. - Clinical data from the global PEDFIC Phase III trial demonstrated that 55% of patients achieved pruritus reduction with odevixibat compared to 30% on placebo. - The treatment offers a non-surgical alternative for managing debilitating symptoms including severe itching, sleep disruption, and impaired cognitive development in PFIC patients.
- Eisai Co., Ltd. received orphan drug designation from Japan's Ministry of Health, Labour and Welfare for tazemetostat hydrobromide (Tazverik®) to treat unresectable INI1-negative epithelioid sarcoma that has progressed after chemotherapy. - Epithelioid sarcoma is an extremely rare soft tissue cancer accounting for only 1% of all soft tissue sarcomas, with just 174 cases registered across major Japanese hospitals over a 10-year period from 2006 to 2015. - The EZH2 inhibitor targets a key molecular pathway in epithelioid sarcoma, where loss of INI1 protein occurs in over 90% of cases, leading to EZH2 activation that drives tumor onset and malignant progression. - A Phase II investigator-initiated trial (TAZETTA trial) led by the National Cancer Center Hospital is currently underway to evaluate tazemetostat's efficacy in this indication.
- Mitsubishi Research Institute and Astellas Pharma have signed a memorandum of understanding to support Japanese drug-discovery startups in their global expansion efforts. - The collaboration operates under Japan's Ministry of Health, Labour and Welfare's Medical Innovation Support Office (MEDISO), which has supported over 1,200 startup and academic ventures since 2018. - Participating startups will gain access to laboratory and office space at Astellas' SakuLab-Tsukuba facility, along with expert consultations and networking opportunities with Astellas researchers. - The initiative aims to strengthen Japan's position as a global drug discovery hub and address the gap between advanced life-sciences technologies and their practical application.
- Japan is advancing decentralized clinical trials (DCTs) in oncology to address geographic barriers and improve access for patients with rare cancers or low-frequency genetic mutations. - Recent regulatory developments include 2023 guidelines for electronic informed consent and 2024 guidance on using remotely collected data, gradually establishing a legal framework for DCT adoption. - Three emerging DCT models in Japan include physician-led fully-remote trials, sponsor-led hybrid approaches, and remote pre-screening systems, all aimed at reducing patient travel burden while maintaining data integrity.
- Astellas Pharma has submitted a New Drug Application to Japan's MHLW for avacincaptad pegol, potentially becoming the first approved treatment for geographic atrophy in Japan. - The submission is supported by GATHER1 and GATHER2 clinical trials, which demonstrated the drug's ability to slow GA lesion growth with a favorable safety profile over two years. - Geographic atrophy affects over 5 million people globally, with 66% at risk of becoming legally blind without treatment, highlighting the significant unmet medical need.
